Full Press Release Details
SOUTH JORDAN, Utah, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced 24-month efficacy findings from the non-randomized AVG cohort of the WAVE trial. Results of the AVG cohort were presented during the Late-Breaking Clinical Trials session at the annual VIVA Foundation3Venous Endovascular Interventional Strategies (VEINS) conference held in Las Vegas, NV.
For the millions of patients diagnosed with advanced kidney disease, hemodialysis is a life-saving treatment that replaces the function of the kidneys. The administration of hemodialysis requires ongoing vascular access (access to blood vessels) that is commonly achieved through the surgical creation of an AVG in a central or peripheral vein. However, complications, such as stenosis (narrowing) or occlusion (blockage), in the patient veins required for vascular access are common. The WRAPSODY® Cell-Impermeable Endoprosthesis (CIE) is intended to help physicians restore vascular access in patients on hemodialysis who experience these complications.
The WAVE trial was designed to capture the performance of the WRAPSODY CIE. TLPP and ACPP outcomes were used to evaluate the ability of the device to restore functional vascular access in trial patients. Forty-three centers across the United States, South America, and the United Kingdom participated in the trial.
In the non-randomized arm of the WAVE trial, 112 patients with a stenosis or occlusion in their AVG were treated with the WRAPSODY CIE. The TLPP at 6 months was compared to historical outcomes (i.e., performance goals) and then documented over 24 months. The TLPP at 6 monthsexceededthe established performance goal (81.4% vs. 60%; p<0.0001). At 12 and 24 months, the TLPP for patients treated with the WRAPSODY CIE were 60.2% and 41.7%, respectively. At 12 and 24 months, the ACPP for patients treated with the WRAPSODY CIE were 36.2% and 25.7%, respectively.
“The ability of the WRAPSODY CIE to offer patients with a failing AVG the opportunity to extend vascular access is promising; the 24-month efficacy results will be of the utmost importance to physicians,” said Mahmood K. Razavi, MD, FSIR, FSVM, Interventional Radiologist and Medical Director of Clinical Research at St. Joseph Heart and Vascular Center in Orange, CA, and Co-Global Principal Investigator of the WAVE trial. Dr. Razavi presented results from the non-randomized arm of the trial at the VEINS conference.
“The opportunity to provide physicians with the evidence they need to inform patient care is a key priority at Merit,” said Martha G. Aronson, Merit’s President and Chief Executive Officer. “The long-term data from the non-randomized arm of the WAVE trial have helped us to appreciate the value that the WRAPSODY CIE can provide patients and physicians.”
On December 19, 2024, the WRAPSODY CIE received premarket approval from theUS Food and Drug Administration (FDA). On April 30, 2025, the device was approved byHealth Canada. The WRAPSODY CIE previously received the Conformité Européenne (CE) Mark for commercial use in the European Union and is available in Brazil.
For more information on the WRAPSODY CIE within the United States, please visit:https://www.merit.com/product/wrapsody-cie/. For information on the device outside of the United States, please visit:https://www.merit.com/product/merit-wrapsody/.
In the United States and Canada, real-world clinical outcomes of the WRAPSODY CIE are being evaluated in the WRAP North America Registry, which is designed to enroll up to 250 patients. For additional information on Merit’s WRAP North America Registry, please visit:https://clinicaltrials.gov/study/NCT06807099.
Outside of North America, real-world outcomes of the WRAPSODY CIE are being evaluated in theWRAP Global registry.
1TLPP was defined as the proportion of patients who did not require an intervention due to clinically driven target lesion revascularization or target lesion thrombosis.
2ACPP was defined as the proportion of patients without loss of vascular access anywhere within the circuit from the time of their initial treatment to the need for reintervention or abandonment of vascular access.
3The VIVA Foundation is a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education, advocacy, research, and philanthropy. To learn more about The VIVA Foundation, please visitwww.viva-foundation.org.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
Any forward-looking statements set forth in this release are subject to risks and uncertainties such as those described in Merit's filings with the U. S. Securities and Exchange Commission (“SEC”). For discussion of the risks and uncertainties which may affect Merit’s business, operations and financial condition, see Part I, Item 1A, “Risk Factors” in Merit’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC, which Merit updated in Part II, Item 1A, “Risk Factors” in Merit’s Quarterly Reports on Form 10-Q for the quarters ended March 31, 2025, June 30, 2025 and September 30, 2025, which Merit filed with the SEC. Actual results will likely differ, and may differ materially, from anticipated results.
ABOUT MERIT
Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling more than 800 individuals. Merit employs approximately 7,400 people worldwide.
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